Medical Technology

Medical technology DIN EN ISO 13485:2007

Medical technology norm EN ISO 13485: 2007 is the current standard of the quality management system for medical products and lays down the requirements for regulatory purposes in respect of such medical products. This means that DIN EN ISO 13485: 2007 corresponds to certification of a company and, in this way, satisfies the qualitative and legal requirements for the manufacture of medical products.

The basic features of medical technology norm DIN EN ISO 13485: 2007 include medical product rights and the related risk management. In all sectors of medical product manufacture, Meding GmbH operates strictly according to the guidelines for this standard.

It is important for all companies which adhere to DIN EN ISO 13485: 2007 and which purchase and must document medical products that the supplier maintains an appropriate quality management system in accordance with the guidelines of DIN EN ISO 13485: 2007. This provides proof of being a qualified supplier with the competence to manufacture and subsequently sell medical products.

Finally, proof of adherence to DIN EN ISO 13485: 2007 benefits not only Meding GmbH's customers, but also their end users. This is because DIN EN ISO 13485: 2007 creates the trust which is so important for medical products.